A Study to Evaluate the Effectiveness of NuvaRing® to Prevent Pregnancies in Chinese Women (P06450)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01277211
First received: January 12, 2011
Last updated: September 30, 2014
Last verified: September 2014
Results First Received: September 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Contraception
Interventions: Drug: ENG 120 µg + EE 15 µg intravaginal ring
Drug: DRSP 3 mg + EE 30 µg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 983 participants randomized, 946 received treatment and 37 discontinued prior to receiving treatment.

Reporting Groups
  Description
ENG-EE (NuvaRing) Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
DRSP-EE Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.

Participant Flow:   Overall Study
    ENG-EE (NuvaRing)     DRSP-EE  
STARTED     738     245  
Treated     714     232  
COMPLETED     588     182  
NOT COMPLETED     150     63  
Adverse Event                 60                 22  
Pregnancy                 9                 4  
Lost to Follow-up                 14                 9  
Did not wish to continue                 17                 0  
Withdrew Consent                 9                 9  
Non-compliance with protocol                 13                 4  
Did not meet protocol eligibility                 1                 0  
Administrative                 3                 0  
Pregnancy wish                 0                 2  
Discontinued prior to treatment                 24                 13  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All Subjects Treated (AST) group, which consisted of all randomized participants who used at least one ring/pill.

Reporting Groups
  Description
ENG-EE (NuvaRing) Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
DRSP-EE Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
Total Total of all reporting groups

Baseline Measures
    ENG-EE (NuvaRing)     DRSP-EE     Total  
Number of Participants  
[units: participants]
  714     232     946  
Age  
[units: Years]
Mean ± Standard Deviation
  31.8  ± 4.0     31.2  ± 3.9     31.7  ± 4.0  
Gender  
[units: Participants]
     
Female     714     232     946  
Male     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pearl Index, by Treatment Group   [ Time Frame: Up to 1 year ]

2.  Secondary:   Percentage of Participants With Intermenstrual (Breakthrough) Bleeding/Spotting, by Cycle   [ Time Frame: Up to 1 year ]

3.  Secondary:   Percentage of Participants With Absence of Withdrawal Bleeding, by Cycle   [ Time Frame: Up to 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharpe & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01277211     History of Changes
Other Study ID Numbers: P06450
Study First Received: January 12, 2011
Results First Received: September 8, 2014
Last Updated: September 30, 2014
Health Authority: China: Food and Drug Administration